Urine HPV testing for cervical cancer screening in HIV-infected women in South Africa
Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
This study tests whether using urine samples to check for HPV can help screen for cervical cancer in women living with HIV in South Africa.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Westdene, Johannesburg) |
| Trial ID | NCT05413798 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of urine samples for screening cervical cancer in women living with HIV in South Africa. It aims to validate high-risk HPV testing on urine specimens and compare its sensitivity and specificity to traditional self- or clinician-collected samples. Given the high risk of cervical cancer among HIV-infected women, this research seeks to provide a more accessible and scalable screening method in low-resource settings. The study will involve participants aged 25 and older who can provide informed consent and meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 and older who are confirmed to be HIV-positive.
Not a fit: Patients who are pregnant, have a history of cervical cancer, or have been vaccinated against HPV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify cervical cancer screening and improve early detection among HIV-infected women.
How similar studies have performed: While urine HPV testing has been explored in other contexts, this specific approach for HIV-infected women in low-resource settings is novel and has not been extensively validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. Confirmed HIV-1 infection 2. Age 25 years and older. 3. Be willing and able to provide written informed consent. Exclusion Criteria: 1. Pregnant or intend to become pregnant within 90 days of enrollment 2. Have been screened for cervical cancer within the preceding year (365 days) 3. Have an active sexually transmitted infection (STI; women may participate once treated) 4. Have a surgically absent cervix 5. Have a history of cervical cancer 6. have been vaccinated against HPV.
Where this trial is running
Westdene, Johannesburg
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital — Westdene, Johannesburg, South Africa (Recruiting)
Study contacts
- Principal investigator: Carla Chibwesha, MD, MSc — Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
- Study coordinator: Cheryl Hendrickson
- Email: cheryl_hendrickson@med.unc.edu
- Phone: 919-843-2541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.